# K091633: Tephaflex Surgical Film

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Aug 7, 2009 after 64 days
- Product code: OOD (Surgical Film)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TephaFLEX Surgical Film: named in the summary without a submission number
- (no number) TephaFLEX Absorbable Mesh: named in the summary without a submission number
- (no number) Surgi-Wrap Film: named in the summary without a submission number

## Indications for use
TephaFLEX® Surgical Film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera. NOTE: The TephaFLEX Surgical Film is not intended to be placed transvaginally. The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy.

Source page: https://510kreport.com/device/K091633
Methodology: https://510kreport.com/methodology